FMT for Autism
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.
How does the treatment FMT for autism differ from other treatments?
FMT (Fecal Microbiota Transplantation) is unique because it involves transferring gut bacteria from a healthy donor to a patient, which is different from other autism treatments that typically focus on cognitive or behavioral therapies. This approach is novel as it targets the gut-brain connection, which is not a standard focus in autism treatments.12345
What is the purpose of this trial?
The purpose of this study is to find out if transplant of fecal matter (stool), also known as fecal microbiota transplantation (FMT), from a healthy person into the intestines of children and young adults with Autism Spectrum Disorder (ASD).For this study children between the ages of 5-17years will be recruited over 2 years. Children will be recruited who receive an ASD diagnosis using the gold-standard Autism Diagnosis Observation Schedule -2 (ADOS-2) using module 1, 2 or 3 (none, limited or no moderate expressive language). Children diagnosed with these modules of the ADOS-2 may be at greater risk for GI disorders and rigid-compulsive behaviors. Additional assessment of rigid-compulsive behaviors and social communication will be done using the Repetitive Behavioral Scales-Revised (RBS-R) and Social Responsiveness Scale-2 (SRS-2), respectively. KBIT (the Kaufman Brief Intelligence Test) is used at baseline to obtain patient IQ. Total evaluation time is approximately 90 minutes. Following baseline symptom evaluation, a medical exam will be performed to determine whether each child is expressing specific GI symptoms. In addition, parents will fill out the Questionnaire for Pediatric Gastrointestinal Symptoms- Rome III (QPGS-III). Once an ASD diagnosis is confirmed, FMT treatment will be initiated, which typically occurs within 4-6 weeks of the initial diagnosis. Half 50% of the children (n=5) will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy and the other 50% off children (n=5) will receive Saline solution as Placebo control through upper endoscopy.Subjects will have a total of 5 visits within 24 weeks including phone call follow up on Day 7 after FMT.
Research Team
Sonia Michail, MD
Principal Investigator
Children's Hospital Los Angeles
Pat Levitt, Ph.D
Principal Investigator
Children's Hospital Los Angeles
Eligibility Criteria
This trial is for children aged 5-17 with Autism Spectrum Disorder (ASD) who have gastrointestinal symptoms. They must be diagnosed using specific autism and GI symptom assessments, need an upper GI endoscopy, and not have any severe sensory or motor problems, genetic syndromic disorders, significant renal/liver dysfunction, immunodeficiency conditions, or severe food allergies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Evaluation
Baseline symptom evaluation and medical exam to determine GI symptoms, including assessments using ADOS-2, RBS-R, SRS-2, and KBIT
Treatment
Participants receive FMT or placebo through upper endoscopy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a phone call follow-up on Day 7
Treatment Details
Interventions
- FMT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Los Angeles
Lead Sponsor